1. Technical Field
This invention relates to a method for performing a target analyte assay of a thin film anticoagulated blood sample, where the target analyte is the presence or absence of specific phagocytosis and/or binding of particles coated with a particular antigen or antigens by white blood cells, which blood sample contains the white blood cells present in the anticoagulated blood sample, and detectable first type particles coated with the particular antigen or antigens present on the surface which antigens are similar or identical to the antigens expressed by the defined pathological agent. More particularly, the present invention relates to electronic detection, quantization and characterization of phagocytosis and/or binding of detectable substances in human and animal biological fluids such as whole blood, or other fluids containing white blood cells, which characterization is performed in a thin chamber on a quiescent thin film fluid sample containing white blood cells, said chamber having at least two parallel planar walls, at least one of which is transparent. Lyme disease is used only as an example of one infectious disease that can be detected by this process. The present invention applies to all infectious agents that are combated by the biologic process of phagocytosis, some examples being gonorrhea or pneumococcal infection, as well as others.
2. Background Information
U.S. Pat. No. 5,985,595 Krider et al relates to diagnostic tests for the rapid detection of the presence of pathogens in human or animal blood. The blood sample being examined is spread on slides, air dried, fixed, stained and examined using a microscope. This patent is incorporated herein by reference in its entirety.
It would be desirable to be able to perform the diagnostic tests for the presence of the pathogens described in Krider et al in a more rapid and more simple manner that does not require that the sample be spread on slides, air dried, fixed, stained or examined with a microscope by a technician and that can be performed at the point of care.